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Class II: temporary or reversible health riskTerminated

Sprayology Cold + Flu Relief Recall

Cold + Flu Relief, Homeopathic Oral Spray, 1

Sprayology · Gaithersburg, MD

Risk level
Class II
Reported by FDA
Nov 7, 2018
Recall ID
D-0112-2019
Check your lot numberHow we source this data

Summary

Sprayology recalled Cold + Flu Relief starting Oct 9, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0112-2019 on Nov 7, 2018. Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Status: Terminated.

Why it was recalled

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Product description

Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1

Lot numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

Distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0112-2019
Classification
Class II
Status
Terminated
Recall initiated
Oct 9, 2018
FDA report date
Nov 7, 2018
Quantity
2,565 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Sprayology

Original FDA data

Every field from FDA enforcement report D-0112-2019, exactly as published.

Show all FDA fields
City
Gaithersburg
State
MD
Status
Terminated
Country
United States
Event ID
81218
Address
18914 Bonanza Way
Code information
All lots within expiry
Postal code
20879-1512
Report date
Nov 7, 2018
Product type
Drugs
Recall number
D-0112-2019
Classification
Class II
Recalling firm
Sprayology
Product quantity
2,565 bottles
Termination date
Apr 18, 2019
Reason for recall
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
Oct 9, 2018
Initial firm notification
Press Release
Center classification date
Oct 30, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0112-2019, published Nov 7, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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